Nonpharmacologic Pain Management for Chronic Back Pain

(BeatPain Utah Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Utah

Disqualifiers: Pregnancy, Substance use treatment, Spine surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals with chronic back pain manage their pain without relying on opioids. It tests two telehealth treatments: a brief pain teleconsult (nonpharmacologic pain management) and telehealth physical therapy. Some participants will receive only the brief teleconsult, while others will also undergo physical therapy. The trial seeks individuals who have experienced back pain for at least three months, have recently visited a specific health center, and have access to a phone or video for telehealth sessions. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering participants early access to potentially effective pain management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on non-drug treatments for back pain, so it's best to ask the trial organizers for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that non-drug treatments for chronic pain, such as telehealth physical therapy, are generally safe. Studies indicate that telehealth methods, including video calls, are usually well-received and help manage chronic pain without major safety issues.

Telehealth physical therapy, in particular, has been safely used for chronic back pain. This method allows therapists to guide patients through exercises and treatments remotely. Reports suggest that this approach typically does not cause serious side effects.

Overall, using telehealth to manage chronic back pain is a safe option. Many people find it a convenient way to receive care without leaving home, reducing the need for opioids and improving access to treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for chronic back pain involve medications, physical therapy, or even surgery, which can be time-consuming and costly. Researchers are excited about the new approaches being tested because they leverage telehealth technology to manage pain more conveniently. The Brief Pain Teleconsult offers quick, virtual consultations that aim to rapidly identify effective pain management strategies without the need for medication. Meanwhile, combining this with Telehealth Physical Therapy provides a comprehensive, digitally-delivered treatment plan that could reduce the need for in-person visits. This is particularly exciting as it may offer a more accessible and flexible option for patients who struggle to attend traditional appointments.

What evidence suggests that this trial's treatments could be effective for chronic back pain?

Research has shown that non-medication treatments, like those in this trial, can aid in managing chronic pain. Participants in one arm of this trial will receive Brief Pain Teleconsult, which studies have shown helps patients with mild pain achieve better outcomes after telemedicine visits. Another arm will provide both Brief Pain Teleconsult and Telehealth Physical Therapy. Participants in previous studies reported significant improvements in pain levels and mobility with Telehealth Physical Therapy. One study found that remote physical therapy was as effective as in-person sessions. These findings suggest both treatments tested in this trial can help manage chronic back pain and improve quality of life. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with chronic back pain, who have access to telehealth resources and can communicate in English or Spanish. They must have seen an FQHC provider recently but cannot join if they've had recent spine surgery, are pregnant, have non-musculoskeletal causes of back pain, or severe physical restrictions.

Inclusion Criteria

Visited with an FQHC provider (in-person or via telehealth) in the past 90 days

Access to resources necessary to receive telehealth sessions (phone or 2-way video)

I can communicate in English or Spanish.

Exclusion Criteria

I cannot walk on my own for at least 5 minutes, even with help.

My back pain is due to a fracture or a condition like a spinal tumor.

I have had spine surgery within the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Brief Pain Teleconsult

Participants receive a brief teleconsult intervention to manage pain

1-12 weeks

Telehealth sessions

Telehealth Physical Therapy

Non-responders to the initial teleconsult receive a 10-week telehealth physical therapy intervention

10 weeks

Telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Assessments at 12, 26, and 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brief Pain Teleconsult
• Telehealth Physical Therapy

Trial Overview The study tests non-drug treatments for chronic back pain via telehealth to reduce opioid use. It compares telehealth physical therapy and brief pain consultations using electronic health record reminders. The focus is on treatment effectiveness while also collecting data on implementation.

How Is the Trial Designed?

Group I: Brief Pain Teleconsult plus Telehealth Physical Therapy Experimental Treatment 2 Interventions

Participants randomized to Brief Pain Teleconsult plus Telehealth Physical Therapy will receive the brief teleconsult intervention in Phase 1 followed by the 10-week physical therapy intervention. No additional treatment is provided after the 12 week assessment.

Group II: Brief Pain Teleconsult Experimental Treatment 2 Interventions

Participants randomized to Brief Pain Teleconsult will receive the brief teleconsult intervention in Phase 1 (1-12 weeks) Responder status to the Phase 1 treatment will be examined at the 12 week assessment. Participants determined to be non-responders will receive the Telehealth Physical Therapy intervention. Responders receive no additional treatment.

Brief Pain Teleconsult is already approved in United States for the following indications:

Approved in United States as Brief Pain Teleconsult for:

• Chronic low back pain

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

A study involving 27 participants with chronic low back disorders showed that a virtual care model using videoconferencing between nurse practitioners and physical therapists had diagnostic and management agreement similar to traditional in-person assessments.

The virtual model demonstrated strong concordance for urgent surgical referrals and recommendations for physical therapy follow-up, suggesting it can effectively enhance access to care for rural patients with chronic low back issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A physical therapist and nurse practitioner model of care for chronic back pain using telehealth: Diagnostic and management concordance. Lovo, S., Harrison, L., O'Connell, ME., et al.[2022]

An integrated cognitive-behavioral and physical therapy protocol for chronic pain management has been developed and successfully implemented for veterans using videoconferencing technology.

This approach highlights the effectiveness of interdisciplinary treatments for chronic pain and provides recommendations for overcoming challenges in remote delivery of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-pain management: use of videoconferencing technology in the delivery of an integrated cognitive-behavioral and physical therapy group intervention. Palyo, SA., Schopmeyer, KA., McQuaid, JR.[2022]

In a study of 1090 participants with low back pain, clinic-based multidisciplinary therapy (C-IPU) resulted in significantly greater pain relief and reductions in disability compared to web-based therapy (O-IPU).

Both treatment approaches effectively reduced opioid use, with 19% of C-IPU and 21.5% of O-IPU participants ceasing opioid use by the end of treatment, highlighting the effectiveness of both methods in managing low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Clinic Versus Web-Based Multidisciplinary Exercise-Based Rehabilitation for Treatment of Low Back Pain: Prospective Clinical Trial in an Integrated Practice Unit Model. Raiszadeh, K., Tapicer, J., Taitano, L., et al.[2021]

A telehealth physical therapy program for chronic low back pain was feasible and well-received by participants, with 69.8% initiating the program and significant improvements in disability and pain reported at follow-ups.

Participants generally expressed satisfaction with telehealth PT, although only 39.5% felt it matched the quality of in-person therapy, highlighting areas for improvement in the telehealth experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Telehealth Physical Therapy Provided Using Real-Time, Videoconferencing for Patients With Chronic Low Back Pain: A Longitudinal Observational Study. Fritz, JM., Minick, KI., Brennan, GP., et al.[2022]

A multidisciplinary approach that combines pharmacological and non-pharmacological interventions is most effective for managing pain, particularly in patients with rheumatic diseases and musculoskeletal conditions like low back pain.

This review highlights the importance of non-pharmacological interventions, such as psychological support, physical exercise, and patient education, in pain management, with evidence supporting their use across different age groups, including children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacological treatment of pain in rheumatic diseases and other musculoskeletal pain conditions. Cunningham, NR., Kashikar-Zuck, S.[2022]

Non-pharmacological therapies are important for managing chronic pain and are valued by both patients and caregivers.

To ensure the safe implementation of these therapies, appropriate regulatory guidelines and specific training for caregivers are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The non-pharmacological management of chronic pain]. Berlemont, C.[2017]

A pilot study involving 47 chronic pain patients showed that group cognitive behavioral therapy (CBT) delivered via teletherapy is feasible and well-tolerated, with 62.5% of participants rating it as very helpful.

Both online and in-person CBT groups demonstrated similar modest improvements in coping with chronic pain, suggesting that online therapy could be an effective alternative to traditional in-person sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online group pain management for chronic pain: Preliminary results of a novel treatment approach to teletherapy. Mariano, TY., Wan, L., Edwards, RR., et al.[2021]

A study involving 31 participants with chronic low back pain showed that telehealth physical therapy (PT) is generally well-received, with many participants reporting positive experiences and advantages such as convenience and cost savings.

However, concerns about the quality of telehealth compared to in-person therapy persisted for some, highlighting the need for improvements like a hybrid approach that combines both methods and offers technical support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Perceptions, Experiences, and Recommendations of Telehealth Physical Therapy for Patients With Chronic Low Back Pain: A Mixed Methods Survey. Skolasky, RL., Kimball, ER., Galyean, P., et al.[2022]

Patients using opioids are less likely to receive recommendations for nonpharmacological treatments, such as physical therapy, indicating a potential gap in multimodal chronic pain care.

Female patients are more likely to be recommended nonpharmacological treatments, while males and those referred for rehabilitation therapies show lower participation rates, suggesting the need for targeted support for these vulnerable groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Predictors of Recommendations for and Participation in Multimodal Nonpharmacological Treatments for Chronic Pain Using Patient-Reported Outcomes and Electronic Medical Records. Bernstein, C., Gillman, AG., Zhang, D., et al.[2021]

Adding telephone support to the Reboot Online pain management program significantly improved participant enrollment (93% vs. 78%) and commencement rates (91% vs. 60%) compared to the program without support, indicating that clinician guidance can enhance initial engagement.

Despite the increased engagement, the overall completion rates and clinical effectiveness of the program were similar between the two groups, suggesting that while support helps get participants started, it may not influence their ability to finish the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Adjunct Telephone Support on Adherence and Outcomes of the Reboot Online Pain Management Program: Randomized Controlled Trial. Gardner, T., Schultz, R., Haskelberg, H., et al.[2022]

Chronic pain treatment should combine both pharmacological and nonpharmacological methods, including options like physical therapy, acupuncture, and music therapy.

While the evidence for the effectiveness of these nonpharmacological treatments is often inconsistent, they can still be beneficial and should be tailored to meet individual patient needs for improved well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nonpharmacological pain therapy for chronic pain]. Drebenstedt, C.[2019]

Citations

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The effectiveness of telemedicine in chronic pain ... Our study demonstrated that patients with mild baseline pain had a higher likelihood of experiencing a successful visit outcome for both in- ...

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Nonpharmacologic Pain Management for Chronic Back Pain A telehealth physical therapy program for chronic low back pain was feasible and well-received by participants, with 69.8% initiating the program and ...

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An update on non-pharmacological interventions for pain ... According to the 2020 Comparative Effectiveness Review from the AHRQ, acupuncture could improve short-term chronic pain intensity with very ...

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A network meta-analysis of randomized controlled trials Integrated non-pharmacological interventions demonstrated greater effectiveness compared to monotherapy in improving PLBP. 1. Introduction.

5. bmjopen.bmj.com bmjopen.bmj.com/content/12/11/e067732

BeatPain Utah: study protocol for a pragmatic randomised ... The BeatPain study will evaluate the implementation and compare the effectiveness of two strategies to provide non-pharmacologic treatment for chronic LBP.

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Nonpharmacologic management of chronic pain in the ... This objective of this review is to describe the scope of the literature on the access to and use of nonpharmacologic therapies to manage chronic pain

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Nonpharmacologic Pain Management in FQHC Primary Care ... The goal of this study is to improve pain management and reduce opioid reliance for patients with chronic back pain in Utah Federally-Qualified Health ...

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Are Nonpharmacologic Interventions for Chronic Low Back ... Many safe and effective nonpharmacologic interventions for chronic low back pain (CLBP) are recommended in treatment guidelines.